Vitamin D and Immune Response in Pulmonary Tuberculosis With and Without Chronic Pulmonary Aspergillosis

Immunological and Epidemiological Features of the Influence of Concomitant Infections on the Course and Outcome of Chronic Respiratory Diseases

The goal of the study is to determine whether vitamin D levels are associated with cytokine profiles in patients with pulmonary tuberculosis, including those with chronic pulmonary aspergillosis.

The main questions it aims to answer are:

• Is there an association between serum 25-hydroxyvitamin D levels and pro- and anti-inflammatory cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α) in patients with active pulmonary tuberculosis?
• Does this association differ in patients with pulmonary tuberculosis complicated by chronic pulmonary aspergillosis compared to those without CPA and to healthy individuals?

Researchers will compare:

• Active pulmonary tuberculosis (PTB) patients
• PTB patients with chronic pulmonary aspergillosis (PTB-CPA)
• Healthy control subjects

To see if differences in vitamin D levels are associated with variations in cytokine responses among these groups.

Participants will:

• Provide blood samples for measurement of serum 25-hydroxyvitamin D
• Undergo laboratory assessment of cytokines (IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α) using ELISA
• Be classified into study groups based on clinical diagnosis (PTB, PTB-CPA, or healthy controls)

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants; Pulmonary Tuberculoses; Chronic Pulmonary Aspergillosis

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Uzbekistan
  • Tashkent
    • Tashkent, Tashkent, Uzbekistan, 100151
      • Department of Immunology of Fungal and Parasitic Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from specialized hospitals, including a national center for infectious diseases of Uzbekistan. The study population comprised patients receiving care for pulmonary tuberculosis, including those with coexisting chronic pulmonary aspergillosis, as well as healthy individuals from the local community.

Description

Inclusion Criteria:

• individuals with confirmed diagnosis of pulmonary tuberculosis
• individuals with confirmed diagnosis of pulmonary tuberculosis and chronoc pulmonary aspergillosis
• Healthy individuals

Exclusion Criteria:

• individuals <18 years old;
• those using immunosuppressants, antifungals and/or antibiotics within the three-month period prior to hospitalization;
• patients with chronic or acute infectious diseases (excluding PTB and CPA) and non-infectious diseases;
• subjects with difficulty collecting samples; and subjects unwilling or unable to provide written informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Pulmonary tuberculosis; patients with active pulmonary tuberculosis before therapy
pulmonary tuberculosis with chronic pulmonary aspergillosis; patients with active pulmonary tuberculosis with concomitant chronic pulmonary aspergillosis
Healthy population; individuals without any health issues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between serum 25-hydroxyvitamin D concentration and cytokine levels	To evaluate the correlation between serum 25-hydroxyvitamin D levels and circulating cytokine concentrations, including IL-1β, IL-4, IL-6, IL-8, IL-10, and TNF-α, in patients with active pulmonary tuberculosis with and without chronic pulmonary aspergillosis. 25-hydroxyvitamin D measurement: Serum concentration (ng/mL), measured using enzyme-linked immunosorbent assay (ELISA). Cytokine measurements: Serum concentrations (pg/mL) of IL-1β, IL-4, IL-6, IL-8, IL-10, and TNF-α, measured using multiplex immunoassay or ELISA. Statistical analysis: Correlation will be assessed using Pearson's or Spearman's correlation coefficient (r), depending on data distribution.	At baseline (single time-point measurement at enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of vitamin D deficiency	Prevalence of participants with vitamin D deficiency across study groups based on standard cut-off values.	At baseline

Collaborators and Investigators

• Sponsor: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: vitamin D; cytokines; tuberculosis; chronic pulmonary aspergillosis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: В2022.1.DSc/Tib669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data will not be publicly shared due to concerns regarding patient confidentiality and the potential risk of identification. Additionally, data sharing is restricted by institutional and ethical regulations governing the use of clinical and laboratory data.

De-identified data may be made available upon reasonable request to the corresponding author, subject to approval by the institutional review board and in accordance with applicable data protection policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No